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Efficacy and Effectiveness of Methylphenidate in Swedish Male Prison Inmates With Attention-deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health and Social Affairs, Sweden
Stockholm County Council, Sweden
Information provided by:
Psychiatry Karolinska
ClinicalTrials.gov Identifier:
NCT00482313
First received: June 4, 2007
Last updated: May 7, 2010
Last verified: August 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy and effectiveness of methylphenidate in treatment of ADHD in Swedish adult male prison inmates diagnosed with ADHD.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
 Drug: PR OROS Methylphenidate
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy of PR OROS Methylphenidate Followed by Open-Label Extension, in Swedish Male Prison Inmates With ADHD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Psychiatry Karolinska:

Primary Outcome Measures:
  • Efficacy of PR OROS methylphenidate on ADHD-symptoms in adult male prison inmates with ADHD, as measured by changes from baseline until endpoint in the observer-rated CAARS. [ Time Frame: Changes from baseline until endpoint at week 5 ] [ Designated as safety issue: No ]
    ADHD-symptoms as measured by changes in the observer-rated CAARS from baseline until endpoint at week 5.


Secondary Outcome Measures:
  • Long-term effectiveness of PR OROS methylphenidate as measured by changes from baseline until endpoint in ADHD-symptoms, global functioning, neuropsychological functioning, and quality of life in adult male prison inmates with ADHD. [ Time Frame: From baseline until endpoint at week 52 ] [ Designated as safety issue: No ]

    ADHD-symptoms as measured by changes in the observer-rated CAARS, and by the self-reported ASRS until endpoint at week 52.

    Global functioning as measured by changes in CGI-S and GAF until endpoint at week 52.

    Neuropsychological functioning, as measured by changes in the Conners CPT II, the QbTestPlus, Digit Span and Span Board from baseline until endpoint at week 52.

    Quality of Life as measured by changes in the Quality of Life Inventory from baseline until endpoint at week 52.


  • Efficacy of PR OROS methylphenidate on ADHD-symptoms and global functioning in adult male prison inmates with ADHD, as measured by changes from baseline until endpoint in self-reported ASRS, CGI-S and GAF [ Time Frame: From baseline until endpoint at week 5 ] [ Designated as safety issue: No ]
  • Safety parameters, as measured by changes in pulse, blood pressure, weight and blood chemistry, from baseline until endpoint. [ Time Frame: From baseline until endpoint at week 52 ] [ Designated as safety issue: Yes ]
    Blood chemistry included counting of red blood cells, white blood cells, blood platelets, and liver enzymes (ALAT, ASAT).

  • Safety parameters as collection of reported adverse events from baseline until endpoint [ Time Frame: From baseline until endpoint at week 52 ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: May 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylphenidate
PR OROS Methylphenidate given orally once daily for 5 weeks. The dosage was as follows: 36 mg per day from day 1-3, 54 mg per day from day 4-7 and 72 mg per day from day 8 until end of 5th week.
 Drug: PR OROS Methylphenidate
PR OROS Methylphenidate given orally once daily for 5 weeks. The dosage was as follows: 36 mg per day from day 1-3, 54 mg per day from day 4-7 and 72 mg per day from day 8 until end of 5th week.
Other Name: Concerta
Placebo Comparator: Sugar pill
Placebo given orally once daily for 5 weeks.
 Drug: Placebo
Sugar pill

Detailed Description:

The purpose of this study is to evaluate the efficacy of Prolonged Release (PR) OROS methylphenidate in fixed dosage as compared to placebo, and the effectiveness of flexible dosage Prolonged Release (PR) OROS methylphenidate in Swedish adult male prison inmates with attention-deficit hyperactivity disorder (ADHD). An initial randomised, double-blind, placebo-controlled parallel group trial for 5 weeks is followed by an open-label extension for maximum 47 weeks, comprising altogether 52 weeks of treatment. A follow-up is carried out 12 and 36 months post-study, respectively.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male, 18-65 years, imprisoned at Norrtalje Prison
  • WURS-score of 36 or more and fulfilling at least 4 out of 6 criteria on ASRS Screener in an initial screening preceding the trial
  • Can read and understand Swedish well enough to participate in the evaluation preceding the trial
  • Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition, (DSM-IV) and confirmed by the neuropsychiatric assessment including structured diagnostic interviews and neuropsychological measurements.
  • At least 14 months left to conditional release.
  • Informed Consent Form to participate in the study signed by the subject.
  • Subject agrees to take only the supplied study drug as treatment for ADHD during the study
  • Subject is able to comply with the study visit schedule and willing and able to complete the protocol-specified assessments.
  • Healthy on the basis of a physical examination and the results of blood biochemistry tests. If the results of the biochemistry tests are not within the normal reference ranges, the subject may be included if the investigator considers the deviations are not clinically relevant.

Exclusion Criteria:

  • Known to be a non-responder to methylphenidate.
  • Known allergy or hypersensitivity to methylphenidate.
  • Any clinically unstable psychiatric condition including, but not limited to, acute mood disorder, bipolar disorder, acute OCD.
  • A diagnosis of substance use disorder (abuse/dependence) according to DSM-IV criteria within 3 months prior to screening evaluation for the study.
  • Known mental retardation.
  • Subjects with history of epileptic seizures, glaucoma, uncontrolled hypertension, angina pectoris, cardiac arrhythmias or structural heart abnormalities.
  • Use of monoamine oxidase inhibitors, fluoxetine, venlafaxine, reboxetine, duloxetine.
  • Use of alpha-2-receptor agonists, neuroleptics, theophylline, coumarin anticoagulants or anticonvulsants.
  • Liver or renal insufficiency. Subjects with hepatitis C without liver insufficiency don´t have to be excluded as long as liver enzymes are followed through the study.
  • Subjects who are suicidal.
  • Lactose intolerance.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482313

Locations
Sweden
Stockholm County Council, Psychiatry Southwest Karolinska
Huddinge, Stockholm, Sweden, 141 86
Sponsors and Collaborators
Psychiatry Karolinska
Ministry of Health and Social Affairs, Sweden
Stockholm County Council, Sweden
Investigators
Principal Investigator: Nils Lindefors, MD, PhD Karolinska Institutet, Psychiatry Southwest, Karolinska University Hospital at Huddinge, Stockholm, e-mail: nils.lindefors@sll.se
  More Information

No publications provided by Psychiatry Karolinska

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nils Lindefors, MD, PhD, Karolinska Institutet, Psychiatry Southwest, Karolinska University Hospital at Huddinge, Stockholm, Sweden
ClinicalTrials.gov Identifier: NCT00482313     History of Changes
Other Study ID Numbers: EudraCT-nr 2006-002553-80
Study First Received: June 4, 2007
Last Updated: May 7, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by Psychiatry Karolinska:
Attention Deficit Hyperactivity Disorder
ADHD
Prison
Treatment
Randomized
 Double-Blind
Placebo Control
Parallel Assignment
Efficacy Study

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
 Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013